Active Cancer NIHR-supported project Lungs & Breathing

A Phase II/III, multisite, randomized master protocol for a global trial of BNT327in combination with chemotherapy and other investigational agents in first-linenon-small cell lung cancer

Funder NIHR (part of DHSC)
Recipient organisation NIHR Lancashire Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Jan 2028

In plain English

AI plain-English summary

A lung cancer trial is testing whether a higher or lower dose of a new drug, BNT327, works better when added to standard chemotherapy for people with previously untreated non-small cell lung cancer. Non-small cell lung cancer is the most common form of the disease, and while chemotherapy remains a standard first treatment, many patients eventually see their tumours progress. This trial aims to find the optimal dose of BNT327—a drug that helps the immune system attack cancer cells—so that future patients receive the most effective dose with the fewest side effects. If the trial identifies a dose that improves outcomes, it could change the standard first-line treatment for both squamous and non-squamous types of non-small cell lung cancer. That would directly affect the roughly tens of thousands of people diagnosed each year in the UK, offering them a longer period before their cancer worsens. The trial uses a master protocol design, which means it can efficiently test multiple drug combinations within the same study framework—a structure that could speed up future lung cancer trials as well.

View original technical description
The purpose of this study is to evaluate the effects of two different doses (either 1400 mg or 2000 mg) of BNT327 (the “study drug”) when combined with chemotherapy (carboplatin with either pemetrexed OR with paclitaxel). This entire study consists of a Phase II study and a Phase III study. The primary purpose of the Phase II study is to determine the best dose for the Phase III part of this study. Phase III will not begin until after the Phase II study is completed because information from the Phase II study is needed before Phase III can begin. Participants will be assigned to either Sub-study A or B depending upon the type of diagnosed NSCLC: • Sub-study A is for participants that have non-squamous type non-small-cell lung cancer,• Sub-study B is for participants that have squamous type non-small-cell lung cancer. Within each sub-study, there are two dose groups. Participants will be randomly assigned to one of these two dose groups (treatment arms): BNT327 at 1400 mg or BNT327 at 2000 mg, plus the standard of care chemotherapy for the participants type of cancer.The maximum time participants might be in this study is for up to 64 months (about 5.3 years). This includes a Screening Period of up to 28 days, a Treatment Period of four 21-day cycles, and a Maintenance Period of continued 21-day cycles (both periods total up to 24 months / 2 years of treatment) and a Follow-up Period: including 30-Day and 90-Day Safety Follow-up Visits and a Survival Follow-up.

Researchers

TaiChung Lam (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

BNT324-01 - A Phase Ib/II, multi-site, open-label,two part trial to evaluate the efficacy,safety, pharmakokinetics,and recommended combination dose of BNT324 with BNT327 in advanced lung cancer
A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer
A Phase II, multi-site, randomized, open-label, parallel group trial of BNT327 in combination with chemotherapy for participants with untreated extensive-stage small-cell lung cancer and participants with previously treated small-cell lung cancer
A Phase II/III, multisite, randomized master protocol for a global trial of BNT327 in combination with chemotherapy and other investigational agents in first-line non-small cell lung cancer
A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer.

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